---
title: Cardiopulmonary Exercise Testing in Severe Mitral Regurgitation
nct_id: NCT03154034
overall_status: COMPLETED
sponsor: University Hospital Regensburg
study_type: OBSERVATIONAL
primary_condition: Mitral Valve Regurgitation
countries: Germany
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03154034.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03154034"
ct_last_update_post_date: 2021-10-11
last_seen_at: "2026-05-12T06:35:21.813Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Cardiopulmonary Exercise Testing in Severe Mitral Regurgitation

**Official Title:** Cardiopulmonary Exercise Testing in Severe Mitral Regurgitation - a Single Center, Observational Echocardiographic Study

**NCT ID:** [NCT03154034](https://clinicaltrials.gov/study/NCT03154034)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 38
- **Lead Sponsor:** University Hospital Regensburg
- **Conditions:** Mitral Valve Regurgitation, Pulmonary Hypertension
- **Start Date:** 2014-08-13
- **Completion Date:** 2018-08-31
- **CT.gov Last Update:** 2021-10-11

## Brief Summary

The purpose of this study is the evaluation of cardiac and pulmonary response to cardiopulmonary exercise in severe mitral regurgitation and its variation under treatment (surgical mitral valve repair, percutaneous mitral valve repair, optimal medical treatment). The study is conducted as a prospective, observational, single-center study. Patients suffering from symptomatic severe mitral regurgitation will be eligible, if they are referred to the University Hospital of Regensburg, Germany, for further diagnostic procedures and heart team discussion. Cardiopulmonary exercise testing is performed comprising standardized stress echocardiography as well as ergospirometry. Additional detailed assessment will be conducted including standardized questionary, clinical examination, transesophageal echocardiography and measurement of biomarkers.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* symptomatic, severe mitral regurgitation
* referral for diagnostic work-up and heart team discussion
* declaration of informed consent

Exclusion Criteria:

* contra-indication for cardiopulmonary stress examination (unstable angina pectoris, left main disease, abnormal electrolyte concentrations, acute decompensation)
* pregnancy
* exercise test on treadmill not possible (amputation of lower extremity, severe arthritis of lower extremities)
* no acceptable acoustic window at rest
```

## Arms

- **Severe mitral regurgitation**

## Primary Outcomes

- **exercise-induced systolic pulmonary arterial pressure** _(time frame: Change from Baseline Exercise-Induced Systolic Pulmonary Arterial Pressure at 1 year)_ — exercise-induced systolic pulmonary arterial pressure measured by stress- echocardiography

## Secondary Outcomes

- **peak oxygen uptake (peakVO2)** _(time frame: Change from Baseline peakVO2 at 1 year)_

## Locations (1)

- University Hospital Regensburg - Department of Internal Medicine II, Regensburg, Germany

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university hospital regensburg - department of internal medicine ii|regensburg||germany` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT03154034*  
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