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Heart Failure, DiastolicINTERACT-HFpEFNCT04154657

Mechanisms of Right Ventricular Adaptation in Patients With Heart Failure With Preserved Ejection Fraction

A study testing conductance catheter measurement in people with Heart Failure, Diastolic, run by Johann Wolfgang Goethe University Hospital at 2 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Biventricular PV-loop studies and advanced imaging to assess left-to-right ventricular interaction in HFpEF: In a group of 30 HFpEF patients with clinical indication for LH/RH catheter investigation, we will perform biventricular PV loop assessment in combination with extensive imaging (MRI, echo) for in-depth… Read more about this study

Who is it for?
Ages 50 to 85 years
Conditions the study is for
Heart Failure, Diastolic
What is being tested?
conductance catheter measurement
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesGermany
Study dates
15 Feb 2020to Jun 2022
Phase
Interventional
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 50 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of HFpEF as follows
  • Heart failure NYHA II or NYHA III
  • LVEF ≥ 50%
  • HFA-PEFF score ≥ 5 OR HFA-PEFF score 2-4 with one of the following criteria:
  • baseline PCWP ≥ 15 mm Hg OR PCWP increase ≥ 10 mm Hg with exercise (~20 Watt)
  • stable medical therapy for last 4 weeks

Who cannot join

  • Significant coronary stenosis > 50% or valvular heart disease requiring intervention
  • coronary or cardiac valvular intervention < 3 months
  • uncontrolled rate of atrial fibrillation
  • Severe chronic kidney disease (MDRD eGFR < 30 ml/min)
  • Life expectancy < 12 months
  • Contraindication to MRI or other planned investigations

Trial locations and contacts

2 sites in 1 country.

Germany2 sites, 2 recruiting
  • Goethe University Hospital

    Frankfurt am Main, Hesse, 60590

    Eike Nagel, MD, +49696301 ext. 84491, eike.nagel@kgu.de

    Valentina M Puntmann, MD, +49696301 ext. 84491, valentina.puntmann@kgu.de

    Recruiting
  • University Hospital Justus-Liebig University

    Giessen, 35392

    Birgit Assmus, MD, +49 641 985 ext. 42637, birgit.assmus@innere.med.uni-giessen.de

    Khodr Tello, MD, +49 641 985 ext. 56087, khodr.tello@innere.med.uni-giessen.de

    Recruiting

Other trials in Germany

About this study

Official title: Disclosing Mechanisms of Right Ventricular Adaptation in Patients With Heart Failure With Preserved Ejection Fraction With and Without Pulmonary Hypertension - Insights From Invasive Hemodynamic and Imaging

Biventricular PV-loop studies and advanced imaging to assess left-to-right ventricular interaction in HFpEF: In a group of 30 HFpEF patients with clinical indication for LH/RH catheter investigation, we will perform biventricular PV loop assessment in combination with extensive imaging (MRI, echo) for in-depth analysis of left-to-right ventricular interaction in the different HFpEF categories, both under baseline and stress (volume challenge and exercise) conditions.

Read the detailed description

The right ventricle is the main determinant of prognosis in pulmonary hypertension . The response of the right ventricle to the structural alterations and increasing afterload in the pulmonary circulation is a complex process. The interplay between neuroendocrine and paracrine signalling and increased afterload may lead to myocardial ischemia and inflammation, resulting in loss of myocytes, myocardial fibrosis and RV-arterial uncoupling. Pulmonary hypertension in the setting of heart failure with preserved ejection fraction (HFpEF-PH) is a frequent complication which is associated with impaired prognosis. HFpEF-PH is defined by a high mean pulmonary artery pressure (> 20 mm Hg), high left ventricular end-diastolic pressure (LVEDP > 15 mm Hg) and a normal systolic left ventricular function with impaired diastolic function. However, not all HFpEF patients develop pulmonary vascular remodelling with a high transpulmonary pressure gradient, and increased pulmonary vascular resistance leading to adverse right ventricular remodelling. Ageing, increased left atrial pressure and stiffness, mitral regurgitation, as well as features of metabolic syndrome, including obesity, diabetes and hypertension, are recognized as clinical risk factors for HFpEF-PH. A main and emerging question in that context is the interplay between the right and left ventricle in HFpEF-PH, and whether diastolic left ventricular failure is the driving force of the hemodynamic and right ventricular functional changes. Recent studies have shown that HFpEF-PH patients demonstrate haemodynamic limitations during exercise, including impaired recruitment of LV preload due to excessive right heart congestion and blunted RV systolic reserve compared to HFpEF without PH . However, up to now, no data exist about the mechanism of interplay between RV, LV and pulmonary haemodynamics in HFpEF and HFpEF-PH. Whereas in patients with HFpEF, PV loop analysis has demonstrated that increased end-diastolic pressure at rest is associated with higher end-diastolic stiffness, and a consistently upwards and leftwards shifted pressure volume relationship during exercise and volume challenge, Gortner et al suggest that reduced LV preload (measured by LV transmural pressure gradient) due to excessive RV congestion, is a major driver for reduced cardiac output in HFpEF-PH. However, preliminary own data in 21 patients with HFpEF demonstrate a more complex relationship with approximately one third of patients not showing an increase of (RV and LV ) end-diastolic pressure volume relation during exercise.

Thus, a simultaneous PV loop-catheterization of LV and RV, in addition to right heart catheter, would therefore provide an enormous gain of knowledge about the interaction of RV and LV and would contribute to a better understanding of the pathophysiology of HFpEF-PH and HFpEF.

Being tested
conductance catheter measurement
Keywords
HFpEF, pulmonary hypertension
Medical subject headings
Heart Failure, Diastolic, Hypertension, Pulmonary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • conductance catheter measurementProcedure or surgery

    Also called pressure volume loop catheter measurement

    biventricular parallel conductance catheter measurement at rest and stress conditions, + CMR at rest and stress

Study groups in NCT04154657
Study groupRoleWhat they receive
biventricular conductance catheterExperimentalpatients with indication for invasive assessment receive right and left heart catheter and parallel biventricular conductance catheter at rest and stress
Receives: Procedure: conductance catheter measurement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. delta Eed

    RV stiffness measured by conductance catheter is reduced alreday in early HFpEF stages

    Measured: immediate after procedure

  2. delta RV volume

    homeometric followed by teterometric adaptation with consecutive dilation of the RV occurs with disease progression from HFpEF-Non-PH ti ICC-PH_HFpEF to cpc-PH-HFpEFprogressive H, impacting position and motion of the septum with stress

    Measured: immediate after procedure

Secondary outcomes (2)
  1. correlation of delta RV longitudinal strain with Eed

    RV longitudinal strain (related to RV EDV) is the best predictor of RV diastolic stiffness (Eed) in HFpEF-PH (correlation analysis)

    Measured: immediate after procedure

  2. delta transmural septal pressure

    acute change of the transmural pressure gradients from rest to stress conditions, adversly impacts LV filling

    Measured: immediate after procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2019
  2. Study start15 Feb 2020
  3. Primary completionDec 2021 (estimated)
  4. Study completionJun 2022 (estimated)

Resources

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 N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
single cohort observational pathophysiologic study
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04154657
Sponsor's protocol ID
Interact_HFpEF
Acronym
INTERACT-HFpEF
Status last verified
Jul 2020
First submitted
4 Nov 2019
Last updated
28 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing conductance catheter measurement in people with Heart Failure, Diastolic, run by Johann Wolfgang Goethe University Hospital at 2 sites 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 6 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: status not confirmed, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Contact Birgit Assmus, MD (+49641985 ext. 42637, birgit.assmus@innere.med.uni-giessen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

delta Eed (time frame: immediate after procedure). The study lists 2 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 28 Jul 2020.

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