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

NCT04154657 | Unknown

• 1 other identifier: Interact_HFpEF
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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 analysis of left-to-right ventricular interaction in the different HFpEF categories, both under baseline and stress (volume challenge and exercise) conditions.

Conditions

Heart Failure, Diastolic

Keywords

HFpEF; pulmonary hypertension

Outcome Measures

Primary Outcomes (2)

• delta Eed

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

  immediate after procedure

• 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

  immediate after procedure

Secondary Outcomes (2)

• correlation of delta RV longitudinal strain with Eed

  immediate after procedure

• delta transmural septal pressure

  immediate after procedure

Study Arms (1)

biventricular conductance catheter

EXPERIMENTAL

patients with indication for invasive assessment receive right and left heart catheter and parallel biventricular conductance catheter at rest and stress

Procedure: conductance catheter measurement

Interventions

conductance catheter measurement PROCEDURE

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

Also known as: pressure volume loop catheter measurement

biventricular conductance catheter

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johann Wolfgang Goethe University Hospital: lead
• University of Giessen: collaborator

Study Sites (2)

Goethe University Hospital

Frankfurt am Main, Hesse, 60590, Germany

RECRUITING

University Hospital Justus-Liebig University

Giessen, 35392, Germany

RECRUITING

MeSH Terms

Conditions

Heart Failure, Diastolic; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases

Central Study Contacts

Birgit Assmus, MD

CONTACT

+49641985; birgit.assmus@innere.med.uni-giessen.de

Khodr Tello, MD

CONTACT

+49641985; khodr.tello@innere.med.uni-giessen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Heart Failure Department, Cardiology

Model Details: single cohort observational pathophysiologic study

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: November 6, 2019
• Study Start: February 15, 2020
• Primary Completion: December 1, 2021
• Study Completion: June 1, 2022
• Last Updated: July 28, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)