Advanced Heart FailurePhase 4SAINTS BNCT05284955
Screening for Advanced Heart Failure IN Stable outPatientS - The SAINTS Study (SAINTS B)
A Phase 4 study testing CardioMEMS HF System and Standard heart failure medical therapy in people with Advanced Heart Failure and Heart Failure With Reduced Ejection Fraction, run by Finn Gustafsson at 1 site in Denmark.
Trial summary
SAINTS B is a randomized, controlled, clinical trial. Patients identified with advanced heart failure in SAINTS A who are unwilling or unable to undergo heart transplantation or left ventricular assist device implantation will be invited to participate in this study. Read more about this study
- Who is it for?
- Ages 19 to 74 years
- Conditions the study is for
- Advanced Heart Failure, Heart Failure With Reduced Ejection Fraction
- What is being tested?
- CardioMEMS HF System and Standard heart failure medical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Mar 2023to 31 Dec 2025
- Phase
- Phase 4
- 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 19 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Included in SAINTS A and fulfilling criteria for advanced HF (i.e., meeting primary endpoint for SAINTS A), although with a lower NT-proBNP cut-off level at ≥ 1000 pg/ml, but not referred for HTx or LVAD due to contraindications or patient preference
- NYHA Functional class III
- Be willing and able to upload pulmonary artery pressure information and comply with the follow-up requirements
Who cannot join
- Systolic blood pressure < 90 mmHg
- Chest circumference of > 165 cm if BMI is ≥35 kg/m2
- Intolerance to all neurohormonal antagonists (i.e., intolerance to Angiotensin Converting Enzyme inhibitors (ACE-I), Angiotensin Receptor Blockers (ARBs), Angiotensin receptor II blocker - neprilysin inhibitor (ARNi), Mineralocorticoid Receptor Antagonists (MRA), hydralazine/isosorbide dinitrate, and betablockers)
- Fluid overload with a maximum (or dose equivalent) diuretic intervention
- Contraindications to 1-month dual antiplatelet therapy or anticoagulation therapy for post implantation
- Significant congenital heart disease that has not been repaired and would prevent implantation of the CardioMEMS pulmonary artery sensor
Show all 10Show fewer
- Implanted with mechanical right heart valve(s)
- Pregnant or planning to become pregnant in the next 12 months
- An active, ongoing infection
- History of current or recurrent (≥2 episodes within 5 years prior to consent) pulmonary emboli and/or deep vein thromboses
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen, 2100
Finn Gustafsson, professor, PhD, DMSci, +45 3545 9743, finng@dadlnet.dk
Johan E Larsson, MD, +45 3545 8096, johanlarsson@dadlnet.dk
About this study
Official title: Efficacy of Pulmonary Pressure Guided Therapy in Stable Outpatients With Advanced Heart Failure - A Randomized Controlled Clinical Trial
SAINTS B is a randomized, controlled, clinical trial. Patients identified with advanced heart failure in SAINTS A who are unwilling or unable to undergo heart transplantation or left ventricular assist device implantation will be invited to participate in this study. Included patients will be randomized in a 1:1 ratio to pharmacological HF treatment guided by an implanted wireless pulmonary artery hemodynamic monitor (CardioMEMS HF system) or usual care consisting of pharmacological HF treatment.
Patients randomized into the CardioMEMS arm will be implanted within 30 (Cardiomems group only) days from randomization. After randomization, patients in both the CardioMEMS and the control arm will be seen at the outpatient clinic at Rigshospitalet after one and 6 months. At the final clinical follow-up visit at 6 months, participants will perform a 6 minute walk test (6MWT), cardiopulmonary exercise test (CPET), fill out a quality of life questionnaire (Kansas City Cardiomyopathy Questionnaire (KCCQ)) and blood samples will be drawn. Patients in the CardioMEMS arm will be managed according to previously published protocols for pulmonary artery pressure optimization (generally mean pulmonary pressure 10-25 mmHg) (Ref 1).
Read the detailed description
Data recording:
Data will be recorded in an online database using an electronic case report form. The investigators will use limits for accepted input, when applicable, on variables to minimize errors and specify which units the observations should be registered in. The investigators will perform quality controls two to four times per year of the database where new entries will be checked for accuracy and completeness.
Statistical considerations:
Sample size:
SAINTS A More than 3000 patients are followed in the HF clinics on Zealand including the greater Copenhagen region. The investigators plan to include 400 patients in the primary outcome analysis (SAINTS A) and hypothesize that 20% will fulfill the modified criteria for advanced HF.
SAINTS B Of the 80 patients identified in the main study, 60 can be expected to be available for randomization to CardioMEMS sensor implantation vs. clinical control. Mean (SD) KCCQ score in advanced HF is expected to be 64 with a standard deviation of 22, (Ref 2) and the investigators aim to see a 30% improvement with CardioMEMS. With a power of 80%, and an alpha of 5% this would require 21 patients in each group. With an expected dropout rate of 15%, a total sample of 48 patients would be required, and due to uncertainty of the estimate, the investigators aim to include 30 patients in each group. In a recent, large RCT on a HFrEF population without advanced HF, the baseline mean (SD) KCCQ score in the placebo group (n = 4112) were 68 (28,5) (Ref 3), which would require 30 patients in each arm for the same power calculation without correction for possible dropout.
Statistical analysis Descriptive statistics will be reported as mean +/- standard deviation (SD) or median (interquartile range (IQR)) depending on distribution. Comparisons between groups at baseline will be performed by unpaired t-tests for normally distributed continues variables, by the Mann-Whitney U test (Wilcoxon rank-sum) for non-normally distributed continuous variables and χ2 or Fisher's exact test for categorical variables.
The primary outcome of change in QoL assessed with the KCCQ from baseline to follow-up at 6 months between the intervention and control group will be tested with a paired t-test (and longitudinal data will be analyzed with linear mixed models with an indicator variable for the treatment group (Ref 4)). Secondary outcomes will be tested with paired and unpaired t-tests or Wilcoxon signed rank test depending on distribution, unadjusted χ2 test and a two-proportion z-test where appropriate. Treatment comparisons will be performed according to the intention to treat principle. Per protocol analyses will also be performed.
- Being tested
- CardioMEMS HF System, Standard heart failure medical therapy
- Keywords
- Advanced heart failure, Pulmonary pressure, Hemodynamics, Remote monitoring, Randomized controlled clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioMEMS HF SystemDevice
The CardioMEMS HF System is a wireless pulmonary artery pressure monitor. We will use measurements from the device to guide medical heart failure therapy.
Standard heart failure medical therapyDrug
Standard heart failure medical therapy as recommended by guidelines.
| Study group | Role | What they receive |
|---|---|---|
| CardioMEMS HF System group | Experimental | Pharmacological heart failure treatment guided by an implanted wireless pulmonary artery hemodynamic monitor (CardioMEMS HF system) Receives: Device: CardioMEMS HF System |
| Standard of care | Active comparator | Standard heart failure medical treatment Receives: Drug: Standard heart failure medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life from baseline to 6 months follow-up measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ) score
The Kansas City Cardiomyopathy Questionnaire (KCCQ) score is a validated measure of quality of life in patients with HF. The range of the scale is 0-100, with higher values representing better quality of life.
Measured: 6 months from inclusion
Secondary outcomes (14)
Mean pulmonary artery pressure and diastolic pulmonary artery pressure
(only CardioMEMS arm)
Measured: 3 months from inclusion
Proportion reaching the preset pressure goal after 3 months
(only Cardiomems arm)
Measured: 3 months from inclusion
Proportion reaching the preset pressure goal adjusted for baseline pulmonary artery pulsatility index
(only Cardiomems arm)
Measured: 3 months from inclusion
Proportion of functioning devices
(only device arm)
Measured: 6 months
Proportion of patients improving > 5 points on KCCQ score
Compared between intervention and control group
Measured: 6 months
6 minute walk test distance in meters
Compared between intervention and control group
Measured: 6 months
NTproBNP after 6 months
Compared between intervention and control group. N-terminal pro B-type natriuretic peptide (NTproBNP) in pg / ml
Measured: 6 months
Estimated glomerular filtration rate (eGFR) in mL/min/1,73 m2
Compared between intervention and control group
Measured: 6 months
Time to hospitalization for heart failure
Measured: 6 months
Days spent alive out of hospital
Measured: 6 months
Mortality
Measured: 6 months
Number of out-patients visits
Measured: 6 months
Number of changes in loop diuretics and neurohomonal blockade
Measured: 6 months
Peak oxygen uptake in ml/kg/min
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start2 Mar 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Advanced Heart FailureStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Finn Gustafsson
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S, Abbott
- Responsible party
- Sponsor-investigator, Finn Gustafsson, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Finn Gustafsson, MD, professor, PhD, DMSci, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284955
- Sponsor's protocol ID
- RH-SAINTS-B
- Acronym
- SAINTS B
- Status last verified
- Mar 2023
- First submitted
- 9 Mar 2022
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Lindenfeld J, Abraham WT, Maisel A, Zile M, Smart F, Costanzo MR, Mehra MR, Ducharme A, Sears SF, Desai AS, Paul S, Sood P, Johnson N, Ginn G, Adamson PB. Hemodynamic-GUIDEd management of Heart Failure (GUIDE-HF). Am Heart J. 2019 Aug;214:18-27. doi: 10.1016/j.ahj.2019.04.014. Epub 2019 May 3. No abstract available.
PubMed 31150790Aaronson KD, Stewart GC, Pagani FD, Stevenson LW, Palardy M, McNamara DM, Mancini DM, Grady K, Gorcsan J, Kormos R, Jeffries N, Taddei-Peters WC, Richards B, Khalatbari S, Spino C, Baldwin JT, Mann DL; REVIVAL Investigators. Registry Evaluation of Vital Information for VADs in Ambulatory Life (REVIVAL): Rationale, design, baseline characteristics, and inclusion criteria performance. J Heart Lung Transplant. 2020 Jan;39(1):7-15. doi: 10.1016/j.healun.2019.09.008. Epub 2019 Sep 14.
PubMed 31679943Teerlink JR, Diaz R, Felker GM, McMurray JJV, Metra M, Solomon SD, Adams KF, Anand I, Arias-Mendoza A, Biering-Sorensen T, Bohm M, Bonderman D, Cleland JGF, Corbalan R, Crespo-Leiro MG, Dahlstrom U, Echeverria LE, Fang JC, Filippatos G, Fonseca C, Goncalvesova E, Goudev AR, Howlett JG, Lanfear DE, Li J, Lund M, Macdonald P, Mareev V, Momomura SI, O'Meara E, Parkhomenko A, Ponikowski P, Ramires FJA, Serpytis P, Sliwa K, Spinar J, Suter TM, Tomcsanyi J, Vandekerckhove H, Vinereanu D, Voors AA, Yilmaz MB, Zannad F, Sharpsten L, Legg JC, Varin C, Honarpour N, Abbasi SA, Malik FI, Kurtz CE; GALACTIC-HF Investigators. Cardiac Myosin Activation with Omecamtiv Mecarbil in Systolic Heart Failure. N Engl J Med. 2021 Jan 14;384(2):105-116. doi: 10.1056/NEJMoa2025797. Epub 2020 Nov 13.
PubMed 33185990Rogers JG, Patel CB, Mentz RJ, Granger BB, Steinhauser KE, Fiuzat M, Adams PA, Speck A, Johnson KS, Krishnamoorthy A, Yang H, Anstrom KJ, Dodson GC, Taylor DH Jr, Kirchner JL, Mark DB, O'Connor CM, Tulsky JA. Palliative Care in Heart Failure: The PAL-HF Randomized, Controlled Clinical Trial. J Am Coll Cardiol. 2017 Jul 18;70(3):331-341. doi: 10.1016/j.jacc.2017.05.030.
PubMed 28705314
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pulmonary Pressure Guided Therapy in Stable Outpatients With Advanced Heart Failure - A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05284955
- Acronym / sponsor ID
- SAINTS B / RH-SAINTS-B
- Keywords
- Advanced heart failure, Pulmonary pressure, Hemodynamics, Remote monitoring, Randomized controlled clinical trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Finn GustafssonUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S, Abbott
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 Mar 2022 (actual)
- 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.
SAINTS B is a randomized, controlled, clinical trial. Patients identified with advanced heart failure in SAINTS A who are unwilling or unable to undergo heart transplantation or left ventricular assist device implantation will be invited to participate in this study. Included patients will be randomized in a 1:1 ratio to pharmacological HF treatment guided by an implanted wireless pulmonary artery hemodynamic monitor (CardioMEMS HF system) or usual care consisting of pharmacological HF treatment.
Patients randomized into the CardioMEMS arm will be implanted within 30 (Cardiomems group only) days from randomization. After randomization, patients in both the CardioMEMS and the control arm will be seen at the outpatient clinic at Rigshospitalet after one and 6 months. At the final clinical follow-up visit at 6 months, participants will perform a 6 minute walk test (6MWT), cardiopulmonary exercise test (CPET), fill out a quality of life questionnaire (Kansas City Cardiomyopathy Questionnaire (KCCQ)) and blood samples will be drawn. Patients in the CardioMEMS arm will be managed according to previously published protocols for pulmonary artery pressure optimization (generally mean pulmonary pressure 10-25 mmHg) (Ref 1).
Detailed description
Data recording:
Data will be recorded in an online database using an electronic case report form. The investigators will use limits for accepted input, when applicable, on variables to minimize errors and specify which units the observations should be registered in. The investigators will perform quality controls two to four times per year of the database where new entries will be checked for accuracy and completeness.
Statistical considerations:
Sample size:
SAINTS A More than 3000 patients are followed in the HF clinics on Zealand including the greater Copenhagen region. The investigators plan to include 400 patients in the primary outcome analysis (SAINTS A) and hypothesize that 20% will fulfill the modified criteria for advanced HF.
SAINTS B Of the 80 patients identified in the main study, 60 can be expected to be available for randomization to CardioMEMS sensor implantation vs. clinical control. Mean (SD) KCCQ score in advanced HF is expected to be 64 with a standard deviation of 22, (Ref 2) and the investigators aim to see a 30% improvement with CardioMEMS. With a power of 80%, and an alpha of 5% this would require 21 patients in each group. With an expected dropout rate of 15%, a total sample of 48 patients would be required, and due to uncertainty of the estimate, the investigators aim to include 30 patients in each group. In a recent, large RCT on a HFrEF population without advanced HF, the baseline mean (SD) KCCQ score in the placebo group (n = 4112) were 68 (28,5) (Ref 3), which would require 30 patients in each arm for the same power calculation without correction for possible dropout.
Statistical analysis Descriptive statistics will be reported as mean +/- standard deviation (SD) or median (interquartile range (IQR)) depending on distribution. Comparisons between groups at baseline will be performed by unpaired t-tests for normally distributed continues variables, by the Mann-Whitney U test (Wilcoxon rank-sum) for non-normally distributed continuous variables and χ2 or Fisher's exact test for categorical variables.
The primary outcome of change in QoL assessed with the KCCQ from baseline to follow-up at 6 months between the intervention and control group will be tested with a paired t-test (and longitudinal data will be analyzed with linear mixed models with an indicator variable for the treatment group (Ref 4)). Secondary outcomes will be tested with paired and unpaired t-tests or Wilcoxon signed rank test depending on distribution, unadjusted χ2 test and a two-proportion z-test where appropriate. Treatment comparisons will be performed according to the intention to treat principle. Per protocol analyses will also be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CardioMEMS HF System group | Experimental | Device: CardioMEMS HF SystemPharmacological heart failure treatment guided by an implanted wireless pulmonary artery hemodynamic monitor (CardioMEMS HF system) |
| Standard of care | Active comparator | Drug: Standard heart failure medical therapyStandard heart failure medical treatment |
Who may qualify
- Ages
- 19 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Included in SAINTS A and fulfilling criteria for advanced HF (i.e., meeting primary endpoint for SAINTS A), although with a lower NT-proBNP cut-off level at ≥ 1000 pg/ml, but not referred for HTx or LVAD due to contraindications or patient preference
- NYHA Functional class III
- Be willing and able to upload pulmonary artery pressure information and comply with the follow-up requirements
Key exclusion criteria (10 listed)
- Systolic blood pressure < 90 mmHg
- Chest circumference of > 165 cm if BMI is ≥35 kg/m2
- Intolerance to all neurohormonal antagonists (i.e., intolerance to Angiotensin Converting Enzyme inhibitors (ACE-I), Angiotensin Receptor Blockers (ARBs), Angiotensin receptor II blocker - neprilysin inhibitor (ARNi), Mineralocorticoid Receptor Antagonists (MRA), hydralazine/isosorbide dinitrate, and betablockers)
- Fluid overload with a maximum (or dose equivalent) diuretic intervention
- Contraindications to 1-month dual antiplatelet therapy or anticoagulation therapy for post implantation
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 |
|---|---|---|
| CardioMEMS HF SystemThe CardioMEMS HF System is a wireless pulmonary artery pressure monitor. We will use measurements from the device to guide medical heart failure therapy. | Device | CardioMEMS HF System group |
| Standard heart failure medical therapyStandard heart failure medical therapy as recommended by guidelines. | Drug | Standard of care |
Primary outcome
Change in Quality of Life from baseline to 6 months follow-up measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ) score
Time frame: 6 months from inclusion
The Kansas City Cardiomyopathy Questionnaire (KCCQ) score is a validated measure of quality of life in patients with HF. The range of the scale is 0-100, with higher values representing better quality of life.
14 secondary outcomes
Mean pulmonary artery pressure and diastolic pulmonary artery pressure
Time frame: 3 months from inclusion
Proportion reaching the preset pressure goal after 3 months
Time frame: 3 months from inclusion
Proportion reaching the preset pressure goal adjusted for baseline pulmonary artery pulsatility index
Time frame: 3 months from inclusion
Proportion of functioning devices
Time frame: 6 months
Proportion of patients improving > 5 points on KCCQ score
Time frame: 6 months
6 minute walk test distance in meters
Time frame: 6 months
NTproBNP after 6 months
Time frame: 6 months
Estimated glomerular filtration rate (eGFR) in mL/min/1,73 m2
Time frame: 6 months
Time to hospitalization for heart failure
Time frame: 6 months
Days spent alive out of hospital
Time frame: 6 months
Mortality
Time frame: 6 months
Number of out-patients visits
Time frame: 6 months
Number of changes in loop diuretics and neurohomonal blockade
Time frame: 6 months
Peak oxygen uptake in ml/kg/min
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Background: PubMed 31150790Lindenfeld J, Abraham WT, Maisel A, Zile M, Smart F, Costanzo MR, Mehra MR, Ducharme A, Sears SF, Desai AS, Paul S, Sood P, Johnson N, Ginn G, Adamson PB. Hemodynamic-GUIDEd management of Heart Failure (GUIDE-HF). Am Heart J. 2019 Aug;214:18-27. doi: 10.1016/j.ahj.2019.04.014. Epub 2019 May 3. No abstract available.
- Background: PubMed 31679943Aaronson KD, Stewart GC, Pagani FD, Stevenson LW, Palardy M, McNamara DM, Mancini DM, Grady K, Gorcsan J, Kormos R, Jeffries N, Taddei-Peters WC, Richards B, Khalatbari S, Spino C, Baldwin JT, Mann DL; REVIVAL Investigators. Registry Evaluation of Vital Information for VADs in Ambulatory Life (REVIVAL): Rationale, design, baseline characteristics, and inclusion criteria performance. J Heart Lung Transplant. 2020 Jan;39(1):7-15. doi: 10.1016/j.healun.2019.09.008. Epub 2019 Sep 14.
- Background: PubMed 33185990Teerlink JR, Diaz R, Felker GM, McMurray JJV, Metra M, Solomon SD, Adams KF, Anand I, Arias-Mendoza A, Biering-Sorensen T, Bohm M, Bonderman D, Cleland JGF, Corbalan R, Crespo-Leiro MG, Dahlstrom U, Echeverria LE, Fang JC, Filippatos G, Fonseca C, Goncalvesova E, Goudev AR, Howlett JG, Lanfear DE, Li J, Lund M, Macdonald P, Mareev V, Momomura SI, O'Meara E, Parkhomenko A, Ponikowski P, Ramires FJA, Serpytis P, Sliwa K, Spinar J, Suter TM, Tomcsanyi J, Vandekerckhove H, Vinereanu D, Voors AA, Yilmaz MB, Zannad F, Sharpsten L, Legg JC, Varin C, Honarpour N, Abbasi SA, Malik FI, Kurtz CE; GALACTIC-HF Investigators. Cardiac Myosin Activation with Omecamtiv Mecarbil in Systolic Heart Failure. N Engl J Med. 2021 Jan 14;384(2):105-116. doi: 10.1056/NEJMoa2025797. Epub 2020 Nov 13.
- Background: PubMed 28705314Rogers JG, Patel CB, Mentz RJ, Granger BB, Steinhauser KE, Fiuzat M, Adams PA, Speck A, Johnson KS, Krishnamoorthy A, Yang H, Anstrom KJ, Dodson GC, Taylor DH Jr, Kirchner JL, Mark DB, O'Connor CM, Tulsky JA. Palliative Care in Heart Failure: The PAL-HF Randomized, Controlled Clinical Trial. J Am Coll Cardiol. 2017 Jul 18;70(3):331-341. doi: 10.1016/j.jacc.2017.05.030.
- Individual participant dataSharing planned: No
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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.
Finn Gustafsson, MD, professor, PhD, DMSci principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CardioMEMS HF System and Standard heart failure medical therapy in people with Advanced Heart Failure and Heart Failure With Reduced Ejection Fraction, run by Finn Gustafsson at 1 site in Denmark.
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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 20 Mar 2023. 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 Denmark. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Finn Gustafsson, MD, professor, PhD, DMSci (+45 3545 9743, finng@dadlnet.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life from baseline to 6 months follow-up measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ) score (time frame: 6 months from inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05284955, which also lists 4 linked publications.
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 20 Mar 2023; AzTrials last refreshed its copy on 6 Nov 2026.