NCT02984631

Brief Summary

In patients with heart failure, elevated filling pressures may contribute to symptoms while not improving cardiac output. The current study is focused on evaluating the relationship between exercise capacity, pulmonary pressures, cardiopulmonary parameters, and symptoms of dyspnea in patients with heart failure during exercise.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 7, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

April 9, 2018

Status Verified

April 1, 2018

Enrollment Period

2.5 years

First QC Date

December 3, 2016

Last Update Submit

April 5, 2018

Conditions

Hypertension, PulmonaryHeart Failure

Outcome Measures

Primary Outcomes (1)

  • Reduction in respiratory rate at matched levels of exercise.

    During the CPET, within 30 minutes of study.

Secondary Outcomes (12)

  • Change in patient symptoms-- dyspnea and leg discomfort (Borg units)

    During the CPET, within 30 minutes of study.

  • Change in ventilatory threshold

    During the CPET, within 30 minutes of study.

  • Change in exercise time

    During the CPET, within 30 minutes of study.

  • Change in heart rate for given level of exercise (work rate in watts)

    During the CPET, within 30 minutes of study.

  • Change in anaerobic threshold

    During the CPET, within 30 minutes of study.

  • +7 more secondary outcomes

Study Arms (2)

Preventing pulm HTN during exercise 2nd

OTHER

Standard of care invasive cardiopulmonary exercise test (CPET) followed by CPET with pre-load control.

Procedure: Preventing pulm HTN during exercise

Preventing pulm HTN during exercise 1st

OTHER

Pre-load control of invasive cardiopulmonary exercise test (CPET) followed by standard CPET.

Procedure: Preventing pulm HTN during exercise

Interventions

Preventing pulm HTN during exercisePROCEDURE

Balloon catheter is inflated within the IVC to maintain pulmonary pressures during exercise.

Preventing pulm HTN during exercise 1stPreventing pulm HTN during exercise 2nd

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects scheduled to undergo an exercise right heart catheterization at El Camino Hospital.
  • New York Heart Association (NYHA) II or III.
  • Subjects must be between 18 and 80 years of age.
  • A left ventricular ejection fraction ≥ 35%.
  • Subjective or objective evidence (e.g. 6 minute walk test) of impaired exercise capacity.
  • Is willing and able to sign an IRB-approved written informed consent

You may not qualify if:

  • Inability to peddle exercise while laying flat.
  • More than mild valve disease.
  • Clinical or objective evidence of inducible myocardial ischemia.
  • Significant lung disease, such as prior diagnosis of COPD.
  • Resting or dynamic outflow tract gradient.
  • Severe pulmonary HTN (\>60mmHg at rest)
  • Moderate to severe RV dysfunction
  • History of DVT, PE
  • Pregnancy (women of child-bearing age, regardless of contraceptive measures, must be willing to take a pregnancy test prior to the study).
  • Recent major surgery or hospitalization (within 30 days)
  • Participation in another clinical study (within 30 days)
  • Advanced neurological disease (e.g. dementia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

El Camino Hospital

Mountain View, California, 94040, United States

RECRUITING

MeSH Terms

Conditions

Hypertension, PulmonaryHeart Failure

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular DiseasesHeart Diseases

Study Officials

  • Daniel W Kaiser, MD

    Electrophysiologist at El Camino Hospital.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel W Kaiser, MD

CONTACT

danielkaisermd@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2016

First Posted

December 7, 2016

Study Start

December 1, 2016

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

April 9, 2018

Record last verified: 2018-04

Locations

US(1)