Heart Failure With Preserved Ejection FractionARTSPREDICTIONNCT06208007
Arterial Stiffening as a Predictor for Diastolic Cardiac Dysfunction and HFpEF
An observational study of Heart Failure With Preserved Ejection Fraction and Cardiovascular Morbidity, run by University Medical Center Goettingen at 1 site in Germany.
Trial summary
Patients at risk for developing heart failure with preserved ejection fraction (HFpEF) will undergo a structured clinical assessment, transthoracic echocardiography and pulse-wave analysis to investigate the association of arterial stiffening and the development of cardiac diastolic dysfuntion and HFpEF. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction, Cardiovascular Morbidity
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 23 Feb 2024to Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients at risk for HFpEF
Who may be able to join
- One or more of the following criteria:
- Age > 60 years
- Arterial hypertension (RR systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg or ≥ 2 antihypertensive drugs)
- Diabetes mellitus Type I or II
- Atrial fibrillation
- Chronic kidney disease (GFR < 60 ml/min/1,73 m2 or urine albumin ≥ 30mg/24h or ACR ≥ 30 mg/g)
Show all 9Show fewer
- BMI ≥ 30 kg/m2
- NYHA ≥ II
- E/e' > 8
Who cannot join
- Left ventricular ejection fraction < 50 %
- Significant valve disease (Grade III or higher)
- History of interventional or surgical valve repair
- Regional wall motion abnormalities
- Respiratory diseases as a known cause for dyspnea
- Atrial flutter or fibrillation during examination
- Hypertrophic/restrictive/arrhythmogenic/dilatative cardiomyopathies including cardiac amyloidosis or sarcoidosis and toxic cardiomyopathy
- History of heart transplantation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Universitätsmedizin Göttingen
Göttingen, Lower Saxony, 37075
Alexander Schulz, Dr. med., 0049 551 3967601, alexander.schulz@med.uni-goettingen.de
About this study
Patients at risk for developing heart failure with preserved ejection fraction (HFpEF) will undergo a structured clinical assessment, transthoracic echocardiography and pulse-wave analysis to investigate the association of arterial stiffening and the development of cardiac diastolic dysfuntion and HFpEF.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HFA-PEFF-Score
Heart Failure Association - Pre-test assessment, Echocardiography and Natriuretic Peptide, Functional testing, Final aetiology; 2-4 points: Diastolic Stress Test or Invasive Haemodynamic Measurements recommended; ≥ 5 points: HFpEF [min. 0 points, max. 6 points]
Measured: 24 months
Development of HFpEF
Defined as ≥ 5 points in HFA-PEFF-Score Heart Failure Association - Pre-test assessment, Echocardiography and Natriuretic Peptide, Functional testing, Final aetiology; 2-4 points: Diastolic Stress Test or Invasive Haemodynamic Measurements recommended; ≥ 5 points: HFpEF [min. 0 points, max. 6 points]
Measured: 24 months
Composite endpoint cardiovascular events
Cardiovascular hospitalisation or death
Measured: 24 months
Secondary outcomes (5)
Change of individual parameters included in the HFA-PEFF-Score
Heart Failure Association - Pre-test assessment, Echocardiography and Natriuretic Peptide, Functional testing, Final aetiology; 2-4 points: Diastolic Stress Test or Invasive Haemodynamic Measurements recommended; ≥ 5 points: HFpEF [min. 0 points, max. 6 points]
Measured: 24 months
Change of NT-proBNP
Measured: 24 months
Change of NYHA-class
Measured: 24 months
Development or aggravation of albuminuria
Measured: 24 months
Change of blood-creatinine
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start23 Feb 2024
- Primary completionJan 2026 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Goettingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Schulz, University Medical Center Goettingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06208007
- Sponsor's protocol ID
- 9/12/23
- Acronym
- ARTSPREDICTION
- Status last verified
- May 2024
- First submitted
- 5 Jan 2024
- Last updated
- 9 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterial Stiffening as a Predictor for Diastolic Cardiac Dysfunction and HFpEF
- ClinicalTrials.gov ID
- NCT06208007
- Acronym / sponsor ID
- ARTSPREDICTION / 9/12/23
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Medical Center GoettingenUniversity, hospital or other
- Study start
- 23 Feb 2024 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 17 Jan 2024 (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.
Patients at risk for developing heart failure with preserved ejection fraction (HFpEF) will undergo a structured clinical assessment, transthoracic echocardiography and pulse-wave analysis to investigate the association of arterial stiffening and the development of cardiac diastolic dysfuntion and HFpEF.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at risk for HFpEF
Key inclusion criteria (9 listed)
- Age > 60 years
- Arterial hypertension (RR systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg or ≥ 2 antihypertensive drugs)
- Diabetes mellitus Type I or II
- Atrial fibrillation
- Chronic kidney disease (GFR < 60 ml/min/1,73 m2 or urine albumin ≥ 30mg/24h or ACR ≥ 30 mg/g)
Key exclusion criteria (8 listed)
- Left ventricular ejection fraction < 50 %
- Significant valve disease (Grade III or higher)
- History of interventional or surgical valve repair
- Regional wall motion abnormalities
- Respiratory diseases as a known cause for dyspnea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in HFA-PEFF-Score
Time frame: 24 months
Heart Failure Association - Pre-test assessment, Echocardiography and Natriuretic Peptide, Functional testing, Final aetiology; 2-4 points: Diastolic Stress Test or Invasive Haemodynamic Measurements recommended; ≥ 5 points: HFpEF [min. 0 points, max. 6 points]
Development of HFpEF
Time frame: 24 months
Defined as ≥ 5 points in HFA-PEFF-Score Heart Failure Association - Pre-test assessment, Echocardiography and Natriuretic Peptide, Functional testing, Final aetiology; 2-4 points: Diastolic Stress Test or Invasive Haemodynamic Measurements recommended; ≥ 5 points: HFpEF [min. 0 points, max. 6 points]
Composite endpoint cardiovascular events
Time frame: 24 months
Cardiovascular hospitalisation or death
5 secondary outcomes
Change of individual parameters included in the HFA-PEFF-Score
Time frame: 24 months
Change of NT-proBNP
Time frame: 24 months
Change of NYHA-class
Time frame: 24 months
Development or aggravation of albuminuria
Time frame: 24 months
Change of blood-creatinine
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
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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.
Universitätsmedizin Göttingen
Göttingen, Germany
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 Heart Failure With Preserved Ejection Fraction and Cardiovascular Morbidity, run by University Medical Center Goettingen at 1 site in Germany.
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 9 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 9 May 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HFA-PEFF-Score (time frame: 24 months). The study lists 3 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 9 May 2024.