Cardiovascular DiseasesCADBIONCT03038750
Molecular Investigation of Genetic Factors in CArDiovascular Diseases Using an BIOresource of Healthy Volunteers
An observational study of Cardiovascular Diseases, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The risk of cardiovascular disease is determined by the complex interplay between an individual's genetic make-up, lifestyle, and the environment. We are investigating three potential genetic risk factors in this observational, cross-sectional, epidemiology pilot study to investigate if and how functional variants… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Eligibility and lifestyle restrictions check., Medical history, demographic and lifestyle factors and Anthropometric measurements: height, weight, and body fat
- Type of treatment
- Injection or infusion
- How many people
- 74 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Aug 2017to 6 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study will only recruit healthy volunteers who have previously consented to being contacted for future studies by the NIHR Cambridge BioResource which is a panel of around 20,000 volunteers, both with and without health conditions, who are willing to be approached to participate in research studies investigating the links between genes, the environment, health and disease. Volunteers who join the Cambridge BioResource have donated their DNA via a blood or saliva sample which is used together with other information, such as gender and ethnicity, to match them to specific research studies. Participants for this study are therefore identified by having the appropriate genetic sequence in one of the three genetic loci we are investigating (EDNRA, PNPLA3 or PROCR).
Who may be able to join
- Volunteers are homozygous for:
- Arm 1: The A-allele of rs6841581, they are assigned to the 'case' group. If they are homozygous for the G-allele, they are assigned to the 'control' group
- Arm 2: The G-allele of rs738409, they are assigned to the 'case' group. If they are homozygous for the C-allele, they are assigned to the 'control' group
- Arm 3: The G-allele of rs867186, they are assigned to the 'case' group. If they are homozygous for the A-allele, they are assigned to the 'control' group
- Volunteers are aged between 18-50 years old
- Volunteers have a BMI:
Show all 14Show fewer
- Arm 1: Between18.5-29.9
- Arm 2: Between 25.0-39.9
- Arm 3: Between 18.5-29.9
- Volunteers are willing not to consume products containing alcohol or caffeine 12 hours prior to procedures. Additionally, volunteers must agree to fast before procedures for:
- Arm 1: At least 4 hours
- Arm 2: At least 8 hours (for visit 2 only)
- Arm 3: At least 4 hours
- Have given written informed consent to participate
Who cannot join
- Volunteers with chronic diseases, including cardiovascular diseases, liver diseases, type 1 and type 2 diabetes autoimmune diseases and cancer
- Biological first-degree relatives (parents, brothers, sisters or children) who are or have suffered from one of the conditions described above
- Current smokers. Ex-smokers are suitable if they stopped smoking >10 years ago
- Volunteers with a diagnosis of hypertension, or history of consistently high blood pressure readings, >140/90 mmHg
- Volunteers with a diagnosis of hypercholesterolemia, or history of consistently high cholesterol levels, e.g. total cholesterol level >6 mmol/l
- Volunteers have ≥3 alcoholic drinks per day
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Public Health and Primary Care
Cambridge, CB1 8RN
About this study
The risk of cardiovascular disease is determined by the complex interplay between an individual's genetic make-up, lifestyle, and the environment. We are investigating three potential genetic risk factors in this observational, cross-sectional, epidemiology pilot study to investigate if and how functional variants identified in large-scale genome wide association studies can explain a predisposition to cardiovascular disease. By determining the molecular mechanisms that are regulated at the EDNRA, PNPLA3 and PROCR CVD risk loci, we hope to translate findings from this study into the clinical setting for better diagnosis, prevention and treatment for patients suffering with cardiovascular disease. Volunteers will enter into one of the study's three arms based on their genotype: EDNRA locus (Arm 1), PNPLA3 locus (Arm 2), or PROCR locus (Arm 3).
Members of the Cambridge Bioresource who match for the target alleles will be invited to participate and will enter into one of the three study arms. All study assessment visits will take place at Addenbrooke's Hospital in collaboration with the University of Cambridge.
Read more
Volunteers will participate in the study for a maximum of 12 months and depending on study arm they are assigned to, they will complete procedures including a medical, demographic and lifestyle factors questionnaire; height, weight and body fat assessments; in addition to blood pressure/heart rate measurements. Minimally invasive procedures including forearm blood flow and venepuncture will be performed to assess the primary objectives of the study.
The hypothesis for arm 1 is that the genetic variant we are investigating at the EDNRA gene locus alters the function of the endothelin receptor A leading to an increased risk of coronary artery disease and large artery stroke.
For study arm 2, we hypothesize that the genetic variant we are investigating in PNPLA3 will increase the risk of Non-alcoholic fatty liver disease but reduce the risk of Coronary Heart Disease.
For study arm 3, we hypothesize that the genetic variant we are investigating in the PROCR locus triggers molecular events that potentially increase the risk of Venous Thrombosis/Venous Thromboembolism nut reducing blood pressure. Furthermore we aim to investigate the anti-inflammatory effects to see if there is an effect on explaining reduced risk of CHD.
This study is funded from the BHF Cambridge Center of Excellence and the Wellcome Trust Institutional Strategic Support Fund.
- Conditions
- Cardiovascular Diseases
- Being tested
- Eligibility and lifestyle restrictions check., Medical history, demographic and lifestyle factors, Anthropometric measurements: height, weight, and body fat, Blood pressure and heart rate, Forearm blood flow: Visit 1 (EDNRA)
- Keywords
- Healthy Volunteers, Genetic Risk Markers for Cardiovascular Disease, Non-Alcoholic Fatty Liver Disease, Coronary Disease, Hypertension, Venous Thromboses, Venous Thromboembolism, Coronary Heart Disease, Coronary Artery Disease
- Medical subject headings
- Cardiovascular Diseases, Non-alcoholic Fatty Liver Disease, Coronary Disease, Hypertension, Venous Thrombosis, Venous Thromboembolism, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eligibility and lifestyle restrictions check.Other
Eligibility will be assessed at each study visit and participants will be informed in advance of their visit.
Medical history, demographic and lifestyle factorsOther
Medical History, participants demographics and lifestyle factors will be assessed by the participant completion of the medical history and ethnicity questionnaires.
Anthropometric measurements: height, weight, and body fatOther
Height measured by stadiometer. Weight and body fat measured by Tanita scale bioelectrical impedance analysis.
Blood pressure and heart rateOther
Parameters will be measured using a validated, automated device while seated and again after 3-5 min standing. All measurements will be done in triplicate.
Forearm blood flow: Visit 1 (EDNRA)Other
Intra-arterial infusion of Phenylephrine at doses of 0.75, 2.5, and 7.5 μg/min for 6 min each (18 min in total). FBF measured in the last 3 minutes. There will be a 30 minute washout with saline followed by Endothelin-1 infusion of at a dose of 5 pmol/min for 90 min.
Forearm blood flow: Visit 2 (EDNRA)Other
Intra-arterial infusion of Sodium nitroprusside infusion at doses of 1, 3, and 10 μg/min for 6 min each (18 min in total). FBF measured in the last 3 minutes. There will be a 20 minute washout with saline followed by infusion of BQ-123 at a dose of 10 nmol/min for 90 min.
Blood biochemistry (PNPLA3)Other
25ml blood will be taken from the participant in a glucose fasting state. Following a high carbohydrate meal, a second 25ml blood sample will be taken. Clinical Biochemistry tests and detailed lipid analysis will be performed.
Blood EPCR function (PROCR)Other
Blood sample taken will be analysed via ELISA and FACS.
Blood platelet coagulation and function (PROCR)Other
Blood sample taken will be analysed using a Platelet coagulation and function assay.
Blood endothelial permeability (PROCR)Other
Blood sample will be analysed in vitro using a permeability assay kit.
Blood leukocyte-endothelium adhesion (PROCR)Other
Blood sample will be analysed in vitro using a leukocyte-endothelium adhesion assay.
Baseline Venepuncture (PNPLA3, Visit 1)Other
Up to 25ml Blood will be taken.
Deuterium water - Loading dose 1 (PNPLA3, Visit 1)Other
Loading dose of 3 g/kg body water.
Deuterium water - Loading dose 2 (PNPLA3, Visit 1)Other
Loading dose of 3 g/kg body water.
Energy-balanced dinner (PNPLA3, Visit 1)Other
Provided following baseline bloods and loading dose 1.
Fasting venepuncture (PNPLA3, Visit 2)Other
Up to 25ml Blood will be taken.
Deuterium water - Maintenance dose (PNPLA3, Visit 2)Other
every hour, maintenance dose 0.04 g/kg body water
Consumption of high carbohydrate meal (PNPLA3, Visit 2)Other
Provided following fasting blood sample.
Postprandial Venepuncture (PNPLA3, Visit 2)Other
Up to 25ml Blood will be taken.
Venepuncture (PROCR)Other
Up to 50ml Blood will be taken.
| Study group | Role | What they receive |
|---|---|---|
| EDNRA Sub-study | Study population will be split into two groups defined by the allele of EDNRA the participant possesses:
Participants Homozygous for the A-allele of EDNRA, are assigned to the 'case' group.
Participants that are Homozygous for the G-allele will be assigned to the 'control' group.
20 participants will be recruited to each group, 40 in total. Receives: Other: Eligibility and lifestyle restrictions check.; Other: Medical history, demographic and lifestyle factors; Other: Anthropometric measurements: height, weight, and body fat; Other: Blood pressure and heart rate; Other: Forearm blood flow: Visit 1 (EDNRA); Other: Forearm blood flow: Visit 2 (EDNRA) | |
| PNPLA3 Sub-study | Study population will be split into two groups defined by the allele of PNPLA3 the participant possesses:
Participants Homozygous for the G-allele of PNPLA3, are assigned to the 'case' group.
Participants that are Homozygous for the C-allele of PNPLA3 will be assigned to the 'control' group.
60 participants will be recruited to each group, 120 in total. Receives: Other: Eligibility and lifestyle restrictions check.; Other: Medical history, demographic and lifestyle factors; Other: Anthropometric measurements: height, weight, and body fat; Other: Blood pressure and heart rate; Other: Blood biochemistry (PNPLA3); Other: Baseline Venepuncture (PNPLA3, Visit 1); Other: Deuterium water - Loading dose 1 (PNPLA3, Visit 1); Other: Deuterium water - Loading dose 2 (PNPLA3, Visit 1); Other: Energy-balanced dinner (PNPLA3, Visit 1); Other: Fasting venepuncture (PNPLA3, Visit 2); Other: Deuterium water - Maintenance dose (PNPLA3, Visit 2); Other: Consumption of high carbohydrate meal (PNPLA3, Visit 2); Other: Postprandial Venepuncture (PNPLA3, Visit 2) | |
| PROCR Sub-study | Study population will be split into two groups defined by the allele of PROCR the participant possesses:
Participants Homozygous for the G-allele of PROCR, are assigned to the 'case' group.
Participants that are Homozygous for the A-allele of PROCR will be assigned to the 'control' group.
30 participants will be recruited to each group, 60 in total. Receives: Other: Eligibility and lifestyle restrictions check.; Other: Medical history, demographic and lifestyle factors; Other: Anthropometric measurements: height, weight, and body fat; Other: Blood pressure and heart rate; Other: Blood EPCR function (PROCR); Other: Blood platelet coagulation and function (PROCR); Other: Blood endothelial permeability (PROCR); Other: Blood leukocyte-endothelium adhesion (PROCR); Other: Venepuncture (PROCR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forearm Blood Flow (Arterial contractility)
Arm 1 specific measurement to be measured using venous occlusion plethysmography. Outcome measure will compare results between case vs control groups.
Measured: 2 years
Blood Biochemistry (Lipoprotein composition/dynamics)
Arm 2 specific measurement collectively comparing the lipid dynamic results between case vs control groups.
Measured: 2 years
EPCR levels/shedding
Arm 3 specific measurement comparing results between case vs control groups.
Measured: 2 years
Platelet aggregation/function
Arm 3 specific measurement to be measured by platelet coagulation function assay comparing results between case vs control groups.
Measured: 2 years
Endothelial permeability
Arm 3 specific measurement to be measured by an endothelial permeability assay comparing results between case vs control groups.
Measured: 2 years
Leukocyte-endothelium adhesion
Arm 3 specific measurement to be measured by a leukocyte-endothelium adhesion assay comparing results between case vs control groups.
Measured: 2 years
Secondary outcomes (2)
Blood pressure
All study arms comparing results between case vs control groups.
Measured: 2 years
Heart rate
All study arms comparing results between case vs control groups.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study start14 Aug 2017
- Primary completion6 Jun 2023
- Study completion6 Jun 2023
Why it stopped: The delay due to suspending the study due to covid, subsequent problems in synthesis, supply and yield of BQ123, prevented completion of the study as planned.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cambridge
- Responsible party
- Principal investigator, Dirk Paul, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Dirk Paul, PhD, Principal investigator, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03038750
- Sponsor's protocol ID
- CADBIO
- Acronym
- CADBIO
- Status last verified
- Feb 2024
- First submitted
- 25 Jan 2017
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant identifiable information is securely held, with restricted access, by the NIHR BioResource. Members of the research team carrying out the procedures will not be able to request the link to decode this information. Only the minimum required participant identifiable information (name and contact details) will be provided to the research team for the purpose of arranging study visits and completing the informed consent process. All research personnel will be sufficiently blinded of the genotype status of the healthy volunteers. All delegated research personnel that is responsible to conduct the data/statistical analysis will only analyse data that is anonymised of any patient identifiable data.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Investigation of Genetic Factors in CArDiovascular Diseases Using an BIOresource of Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03038750
- Acronym / sponsor ID
- CADBIO / CADBIO
- Conditions
- Cardiovascular Diseases
- Keywords
- Healthy Volunteers, Genetic Risk Markers for Cardiovascular Disease, Non-Alcoholic Fatty Liver Disease, Coronary Disease, Hypertension, Venous Thromboses, Venous Thromboembolism, Coronary Heart Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The delay due to suspending the study due to covid, subsequent problems in synthesis, supply and yield of BQ123, prevented completion of the study as planned.
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Cambridge
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 6 Jun 2023 (actual)
- Study completion
- 6 Jun 2023 (actual)
- First posted
- 1 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The risk of cardiovascular disease is determined by the complex interplay between an individual's genetic make-up, lifestyle, and the environment. We are investigating three potential genetic risk factors in this observational, cross-sectional, epidemiology pilot study to investigate if and how functional variants identified in large-scale genome wide association studies can explain a predisposition to cardiovascular disease. By determining the molecular mechanisms that are regulated at the EDNRA, PNPLA3 and PROCR CVD risk loci, we hope to translate findings from this study into the clinical setting for better diagnosis, prevention and treatment for patients suffering with cardiovascular disease. Volunteers will enter into one of the study's three arms based on their genotype: EDNRA locus (Arm 1), PNPLA3 locus (Arm 2), or PROCR locus (Arm 3).
Members of the Cambridge Bioresource who match for the target alleles will be invited to participate and will enter into one of the three study arms. All study assessment visits will take place at Addenbrooke's Hospital in collaboration with the University of Cambridge.
Volunteers will participate in the study for a maximum of 12 months and depending on study arm they are assigned to, they will complete procedures including a medical, demographic and lifestyle factors questionnaire; height, weight and body fat assessments; in addition to blood pressure/heart rate measurements. Minimally invasive procedures including forearm blood flow and venepuncture will be performed to assess the primary objectives of the study.
The hypothesis for arm 1 is that the genetic variant we are investigating at the EDNRA gene locus alters the function of the endothelin receptor A leading to an increased risk of coronary artery disease and large artery stroke.
For study arm 2, we hypothesize that the genetic variant we are investigating in PNPLA3 will increase the risk of Non-alcoholic fatty liver disease but reduce the risk of Coronary Heart Disease.
For study arm 3, we hypothesize that the genetic variant we are investigating in the PROCR locus triggers molecular events that potentially increase the risk of Venous Thrombosis/Venous Thromboembolism nut reducing blood pressure. Furthermore we aim to investigate the anti-inflammatory effects to see if there is an effect on explaining reduced risk of CHD.
This study is funded from the BHF Cambridge Center of Excellence and the Wellcome Trust Institutional Strategic Support Fund.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EDNRA Sub-study | – | Other: Eligibility and lifestyle restrictions check., Other: Medical history, demographic and lifestyle factors, Other: Anthropometric measurements: height, weight, and body fat, Other: Blood pressure and heart rate, Other: Forearm blood flow: Visit 1 (EDNRA), Other: Forearm blood flow: Visit 2 (EDNRA)Study population will be split into two groups defined by the allele of EDNRA the participant possesses: Participants Homozygous for the A-allele of EDNRA, are assigned to the 'case' group. Participants that are Homozygous for the G-allele will be assigned to the 'control' group. 20 participants will be recruited to each group, 40 in total. |
| PNPLA3 Sub-study | – | Other: Eligibility and lifestyle restrictions check., Other: Medical history, demographic and lifestyle factors, Other: Anthropometric measurements: height, weight, and body fat, Other: Blood pressure and heart rate, Other: Blood biochemistry (PNPLA3), Other: Baseline Venepuncture (PNPLA3, Visit 1), Other: Deuterium water - Loading dose 1 (PNPLA3, Visit 1), Other: Deuterium water - Loading dose 2 (PNPLA3, Visit 1), Other: Energy-balanced dinner (PNPLA3, Visit 1), Other: Fasting venepuncture (PNPLA3, Visit 2), Other: Deuterium water - Maintenance dose (PNPLA3, Visit 2), Other: Consumption of high carbohydrate meal (PNPLA3, Visit 2), Other: Postprandial Venepuncture (PNPLA3, Visit 2)Study population will be split into two groups defined by the allele of PNPLA3 the participant possesses: Participants Homozygous for the G-allele of PNPLA3, are assigned to the 'case' group. Participants that are Homozygous for the C-allele of PNPLA3 will be assigned to the 'control' group. 60 participants will be recruited to each group, 120 in total. |
| PROCR Sub-study | – | Other: Eligibility and lifestyle restrictions check., Other: Medical history, demographic and lifestyle factors, Other: Anthropometric measurements: height, weight, and body fat, Other: Blood pressure and heart rate, Other: Blood EPCR function (PROCR), Other: Blood platelet coagulation and function (PROCR), Other: Blood endothelial permeability (PROCR), Other: Blood leukocyte-endothelium adhesion (PROCR), Other: Venepuncture (PROCR)Study population will be split into two groups defined by the allele of PROCR the participant possesses: Participants Homozygous for the G-allele of PROCR, are assigned to the 'case' group. Participants that are Homozygous for the A-allele of PROCR will be assigned to the 'control' group. 30 participants will be recruited to each group, 60 in total. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study will only recruit healthy volunteers who have previously consented to being contacted for future studies by the NIHR Cambridge BioResource which is a panel of around 20,000 volunteers, both with and without health conditions, who are willing to be approached to participate in research studies investigating the links between genes, the environment, health and disease. Volunteers who join the Cambridge BioResource have donated their DNA via a blood or saliva sample which is used together with other information, such as gender and ethnicity, to match them to specific research studies. Participants for this study are therefore identified by having the appropriate genetic sequence in one of the three genetic loci we are investigating (EDNRA, PNPLA3 or PROCR).
Key inclusion criteria (14 listed)
- Volunteers are homozygous for:
- Volunteers are aged between 18-50 years old
- Volunteers have a BMI:
- Volunteers are willing not to consume products containing alcohol or caffeine 12 hours prior to procedures. Additionally, volunteers must agree to fast before procedures for:
- Have given written informed consent to participate
Key exclusion criteria (6 listed)
- Volunteers with chronic diseases, including cardiovascular diseases, liver diseases, type 1 and type 2 diabetes autoimmune diseases and cancer
- Biological first-degree relatives (parents, brothers, sisters or children) who are or have suffered from one of the conditions described above
- Current smokers. Ex-smokers are suitable if they stopped smoking >10 years ago
- Volunteers with a diagnosis of hypertension, or history of consistently high blood pressure readings, >140/90 mmHg
- Volunteers with a diagnosis of hypercholesterolemia, or history of consistently high cholesterol levels, e.g. total cholesterol level >6 mmol/l
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eligibility and lifestyle restrictions check.Eligibility will be assessed at each study visit and participants will be informed in advance of their visit. | Other | EDNRA Sub-study, PNPLA3 Sub-study, PROCR Sub-study |
| Medical history, demographic and lifestyle factorsMedical History, participants demographics and lifestyle factors will be assessed by the participant completion of the medical history and ethnicity questionnaires. | Other | EDNRA Sub-study, PNPLA3 Sub-study, PROCR Sub-study |
| Anthropometric measurements: height, weight, and body fatHeight measured by stadiometer. Weight and body fat measured by Tanita scale bioelectrical impedance analysis. | Other | EDNRA Sub-study, PNPLA3 Sub-study, PROCR Sub-study |
| Blood pressure and heart rateParameters will be measured using a validated, automated device while seated and again after 3-5 min standing. All measurements will be done in triplicate. | Other | EDNRA Sub-study, PNPLA3 Sub-study, PROCR Sub-study |
| Forearm blood flow: Visit 1 (EDNRA)Intra-arterial infusion of Phenylephrine at doses of 0.75, 2.5, and 7.5 μg/min for 6 min each (18 min in total). FBF measured in the last 3 minutes. There will be a 30 minute washout with saline followed by Endothelin-1 infusion of at a dose of 5 pmol/min for 90 min. | Other | EDNRA Sub-study |
| Forearm blood flow: Visit 2 (EDNRA)Intra-arterial infusion of Sodium nitroprusside infusion at doses of 1, 3, and 10 μg/min for 6 min each (18 min in total). FBF measured in the last 3 minutes. There will be a 20 minute washout with saline followed by infusion of BQ-123 at a dose of 10 nmol/min for 90 min. | Other | EDNRA Sub-study |
| Blood biochemistry (PNPLA3)25ml blood will be taken from the participant in a glucose fasting state. Following a high carbohydrate meal, a second 25ml blood sample will be taken. Clinical Biochemistry tests and detailed lipid analysis will be performed. | Other | PNPLA3 Sub-study |
| Blood EPCR function (PROCR)Blood sample taken will be analysed via ELISA and FACS. | Other | PROCR Sub-study |
| Blood platelet coagulation and function (PROCR)Blood sample taken will be analysed using a Platelet coagulation and function assay. | Other | PROCR Sub-study |
| Blood endothelial permeability (PROCR)Blood sample will be analysed in vitro using a permeability assay kit. | Other | PROCR Sub-study |
| Blood leukocyte-endothelium adhesion (PROCR)Blood sample will be analysed in vitro using a leukocyte-endothelium adhesion assay. | Other | PROCR Sub-study |
| Baseline Venepuncture (PNPLA3, Visit 1)Up to 25ml Blood will be taken. | Other | PNPLA3 Sub-study |
| Deuterium water - Loading dose 1 (PNPLA3, Visit 1)Loading dose of 3 g/kg body water. | Other | PNPLA3 Sub-study |
| Deuterium water - Loading dose 2 (PNPLA3, Visit 1)Loading dose of 3 g/kg body water. | Other | PNPLA3 Sub-study |
| Energy-balanced dinner (PNPLA3, Visit 1)Provided following baseline bloods and loading dose 1. | Other | PNPLA3 Sub-study |
| Fasting venepuncture (PNPLA3, Visit 2)Up to 25ml Blood will be taken. | Other | PNPLA3 Sub-study |
| Deuterium water - Maintenance dose (PNPLA3, Visit 2)every hour, maintenance dose 0.04 g/kg body water | Other | PNPLA3 Sub-study |
| Consumption of high carbohydrate meal (PNPLA3, Visit 2)Provided following fasting blood sample. | Other | PNPLA3 Sub-study |
| Postprandial Venepuncture (PNPLA3, Visit 2)Up to 25ml Blood will be taken. | Other | PNPLA3 Sub-study |
| Venepuncture (PROCR)Up to 50ml Blood will be taken. | Other | PROCR Sub-study |
Primary outcome
Forearm Blood Flow (Arterial contractility)
Time frame: 2 years
Arm 1 specific measurement to be measured using venous occlusion plethysmography. Outcome measure will compare results between case vs control groups.
Blood Biochemistry (Lipoprotein composition/dynamics)
Time frame: 2 years
Arm 2 specific measurement collectively comparing the lipid dynamic results between case vs control groups.
EPCR levels/shedding
Time frame: 2 years
Arm 3 specific measurement comparing results between case vs control groups.
Platelet aggregation/function
Time frame: 2 years
Arm 3 specific measurement to be measured by platelet coagulation function assay comparing results between case vs control groups.
Endothelial permeability
Time frame: 2 years
Arm 3 specific measurement to be measured by an endothelial permeability assay comparing results between case vs control groups.
Leukocyte-endothelium adhesion
Time frame: 2 years
Arm 3 specific measurement to be measured by a leukocyte-endothelium adhesion assay comparing results between case vs control groups.
2 secondary outcomes
Blood pressure
Time frame: 2 years
Heart rate
Time frame: 2 years
Results and safety
The study was stopped early (reason given: The delay due to suspending the study due to covid, subsequent problems in synthesis, supply and yield of BQ123, prevented completion of the study as planned.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Individual participant dataSharing planned: No. Participant identifiable information is securely held, with restricted access, by the NIHR BioResource. Members of the research team carrying out the procedures will not be able to request the link to decode this information. Only the minimum required participant identifiable information (name and contact details) will be provided to the research team for the purpose of arranging study visits and completing the informed consent process. All research personnel will be sufficiently blinded of the genotype status of the healthy volunteers. All delegated research personnel that is responsible to conduct the data/statistical analysis will only analyse data that is anonymised of any patient identifiable data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dirk Paul, PhD principal investigator
University of Cambridge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The delay due to suspending the study due to covid, subsequent problems in synthesis, supply and yield of BQ123, prevented completion of the study as planned.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forearm Blood Flow (Arterial contractility) (time frame: 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.