Heart Failure With Preserved Ejection FractionHFpEF-PHTNCT05055180
Right Ventricular Function and Pulmonary Hypertension in HFpEF
An observational study of Heart Failure With Preserved Ejection Fraction, run by Heart Center Leipzig - University Hospital at 1 site in Germany.
Trial summary
In patients with heart failure and preserved ejection fraction (HFpEF) right ventricular (RV) systolic and diastolic dysfunction are prognostically and functionally relevant factors but have mechanistically been neglected so far. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- What is being tested?
- Invasive hemodynamics and myocardial biopsies
- How many people
- 45 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2018to 30 Dec 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: outpatient general cardiology clinic
Who may be able to join
- Clinical signs of heart failure
- Preserved Left ventricular (LV) Ejection Fraction (EF >= 50%)
- Structural Heart Diseases on echocardiogram/ N terminal-pro-brain natriuretic peptide > 125ng/l
- Elevated LV end-diastolic pressure at rest (>15mmHg) or during exertion (>=25mmHg)
- No Heart Failure
- No signs of heart failure
- Preserved Left ventricular (LV) Ejection Fraction (EF >= 50%)
- Normal LV end-diastolic pressure at rest (=<15mmHg) and during exertion (<25mmHg)
Who cannot join
- Significant coronary artery stenosis at time of catheterization
- Acute coronary syndrome or cerebral insult within 1 month of examination
- more than moderate valvular diseases
- pregnancy
- contraindication to cardiac magnetic resonance imaging
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Heart Center Leipzig at Leipzig University
Leipzig, Saxony, 04289
Philipp Lurz, MD, PhD, +49341865252022, Philipp.Lurz@medizin.uni-leipzig.de
Karl-Philpp Rommel, MD, +49341865252529, Karl-Philip.Rommel@medizin.uni-leipzig.de
About this study
Official title: Afterload Dependence of Right Ventricular Myocardial Remodeling and Intrinsic Right Ventricular Myocardial Function in Heart Failure With Preserved Ejection Fraction
In patients with heart failure and preserved ejection fraction (HFpEF) right ventricular (RV) systolic and diastolic dysfunction are prognostically and functionally relevant factors but have mechanistically been neglected so far. In the present study alterations of intrinsic RV (systolic and diastolic) function, as assessed by invasive pressure volume loops, are examined in relation to tissue alterations on myocardial level and to the degree of RV afterload (pulmonary hypertension). Study aim is to gain insights into mechanisms contributing to the development of RV dysfunction and potentially identify new therapeutic targets.
- Being tested
- Invasive hemodynamics and myocardial biopsies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invasive hemodynamics and myocardial biopsiesDiagnostic test
Invasive hemodynamic characterization (biventricular pressure volume loop assessment) and biventricular myocardial biopsies
| Study group | Role | What they receive |
|---|---|---|
| HFpEF with pulmonary hypertension | Invasively diagnosed HFpEF and pulmonary hypertension according to current guidelines Receives: Diagnostic Test: Invasive hemodynamics and myocardial biopsies | |
| HFpEF without pulmonary hypertension | Invasively diagnosed HFpEF without pulmonary hypertension according to current guidelines Receives: Diagnostic Test: Invasive hemodynamics and myocardial biopsies | |
| Patients without HFpEF | Patients without invasive evidence of HFpEF Receives: Diagnostic Test: Invasive hemodynamics and myocardial biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Right ventricular systolic and diastolic function
Assessed with pressure volume loops analysis
Measured: Baseline
Biventricular myocardial fibrosis
Assessed with histopathology
Measured: Baseline
Phosphorylation of structural myocardial proteins
Assessed on myocardial biopsy specimen
Measured: Baseline
Secondary outcomes (2)
Functional capacity
6-Minute Walk Test / Spiroergometry
Measured: Baseline
Myocardial fibrosis on cardiac magnetic resonance
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start1 Oct 2018
- Primary completion30 Nov 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heart Center Leipzig - University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Tuebingen, University Hospital Muenster
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05055180
- Sponsor's protocol ID
- HFpEF-PHT 1.1
- Acronym
- HFpEF-PHT
- Status last verified
- Sep 2021
- First submitted
- 14 Sep 2021
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rommel KP, von Roeder M, Oberueck C, Latuscynski K, Besler C, Blazek S, Stiermaier T, Fengler K, Adams V, Sandri M, Linke A, Schuler G, Thiele H, Lurz P. Load-Independent Systolic and Diastolic Right Ventricular Function in Heart Failure With Preserved Ejection Fraction as Assessed by Resting and Handgrip Exercise Pressure-Volume Loops. Circ Heart Fail. 2018 Feb;11(2):e004121. doi: 10.1161/CIRCHEARTFAILURE.117.004121.
PubMed 29449367von Roeder M, Kowallick JT, Rommel KP, Blazek S, Besler C, Fengler K, Lotz J, Hasenfuss G, Lucke C, Gutberlet M, Thiele H, Schuster A, Lurz P. Right atrial-right ventricular coupling in heart failure with preserved ejection fraction. Clin Res Cardiol. 2020 Jan;109(1):54-66. doi: 10.1007/s00392-019-01484-0. Epub 2019 May 3.
PubMed 31053957
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Afterload Dependence of Right Ventricular Myocardial Remodeling and Intrinsic Right Ventricular Myocardial Function in Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT05055180
- Acronym / sponsor ID
- HFpEF-PHT / HFpEF-PHT 1.1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Heart Center Leipzig - University HospitalUniversity, hospital or other
- Collaborators
- University Hospital Tuebingen, University Hospital Muenster
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 24 Sep 2021 (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.
In patients with heart failure and preserved ejection fraction (HFpEF) right ventricular (RV) systolic and diastolic dysfunction are prognostically and functionally relevant factors but have mechanistically been neglected so far. In the present study alterations of intrinsic RV (systolic and diastolic) function, as assessed by invasive pressure volume loops, are examined in relation to tissue alterations on myocardial level and to the degree of RV afterload (pulmonary hypertension). Study aim is to gain insights into mechanisms contributing to the development of RV dysfunction and potentially identify new therapeutic targets.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HFpEF with pulmonary hypertension | – | Diagnostic Test: Invasive hemodynamics and myocardial biopsiesInvasively diagnosed HFpEF and pulmonary hypertension according to current guidelines |
| HFpEF without pulmonary hypertension | – | Diagnostic Test: Invasive hemodynamics and myocardial biopsiesInvasively diagnosed HFpEF without pulmonary hypertension according to current guidelines |
| Patients without HFpEF | – | Diagnostic Test: Invasive hemodynamics and myocardial biopsiesPatients without invasive evidence of HFpEF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- outpatient general cardiology clinic
Key inclusion criteria (8 listed)
- Clinical signs of heart failure
- Preserved Left ventricular (LV) Ejection Fraction (EF >= 50%)
- Structural Heart Diseases on echocardiogram/ N terminal-pro-brain natriuretic peptide > 125ng/l
- Elevated LV end-diastolic pressure at rest (>15mmHg) or during exertion (>=25mmHg)
- No Heart Failure
Key exclusion criteria (5 listed)
- Significant coronary artery stenosis at time of catheterization
- Acute coronary syndrome or cerebral insult within 1 month of examination
- more than moderate valvular diseases
- pregnancy
- contraindication to cardiac magnetic resonance imaging
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 |
|---|---|---|
| Invasive hemodynamics and myocardial biopsiesInvasive hemodynamic characterization (biventricular pressure volume loop assessment) and biventricular myocardial biopsies | Diagnostic test | HFpEF with pulmonary hypertension, HFpEF without pulmonary hypertension, Patients without HFpEF |
Primary outcome
Right ventricular systolic and diastolic function
Time frame: Baseline
Assessed with pressure volume loops analysis
Biventricular myocardial fibrosis
Time frame: Baseline
Assessed with histopathology
Phosphorylation of structural myocardial proteins
Time frame: Baseline
Assessed on myocardial biopsy specimen
2 secondary outcomes
Functional capacity
Time frame: Baseline
Myocardial fibrosis on cardiac magnetic resonance
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
- Results publication: PubMed 29449367Rommel KP, von Roeder M, Oberueck C, Latuscynski K, Besler C, Blazek S, Stiermaier T, Fengler K, Adams V, Sandri M, Linke A, Schuler G, Thiele H, Lurz P. Load-Independent Systolic and Diastolic Right Ventricular Function in Heart Failure With Preserved Ejection Fraction as Assessed by Resting and Handgrip Exercise Pressure-Volume Loops. Circ Heart Fail. 2018 Feb;11(2):e004121. doi: 10.1161/CIRCHEARTFAILURE.117.004121.
- Results publication: PubMed 31053957von Roeder M, Kowallick JT, Rommel KP, Blazek S, Besler C, Fengler K, Lotz J, Hasenfuss G, Lucke C, Gutberlet M, Thiele H, Schuster A, Lurz P. Right atrial-right ventricular coupling in heart failure with preserved ejection fraction. Clin Res Cardiol. 2020 Jan;109(1):54-66. doi: 10.1007/s00392-019-01484-0. Epub 2019 May 3.
- Individual participant dataSharing planned: Undecided
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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.
Heart Center Leipzig at Leipzig University
Leipzig, 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, run by Heart Center Leipzig - University Hospital 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 8 inclusion and 5 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 24 Sep 2021. 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?
Results are not available in the source record.
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?
Right ventricular systolic and diastolic function (time frame: Baseline). 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?
On the ClinicalTrials.gov record for NCT05055180, which also lists 2 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 24 Sep 2021.