Pulmonary HypertensionCRT in PHNCT03077139
Cardiac Resynchronization Therapy in Pulmonary Hypertension
A study testing Cardiac Resynchronization Therapy (CRT) in people with Pulmonary Hypertension, run by Dr. Daniel P Morin, MD MPH FHRS at 1 site in United States.
Trial summary
This study is being conducted to determine whether patients with advanced pulmonary hypertension when treated with cardiac resynchronization therapy improve hemodynamically and/or receive clinical benefit. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Cardiac Resynchronization Therapy (CRT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2012to 23 Mar 2017
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pulmonary hypertension, defined as pulmonary artery systolic pressure greater than 40 mm Hg by transthoracic echocardiogram or right heart catheterization
- LVEF ≥ 50%
- Baseline 6MWT distant <400 meters
- Baseline NYHA Functional class ≥ III
Who cannot join
- LVEF < 50%
- 6MWT duration > 400 meters
- NYHA Functional class < III
- Left bundle branch block
- Non-sinus rhythm
- Severe aortic stenosis (Aortic valve area < 1 cm2)
Show all 13Show fewer
- Severe mitral regurgitation
- Acute cardiac failure
- Dependency on intravenous inotropies
- Severe obstructive pulmonary disease
- Hypertrophic obstructive cardiomyopathy
- Amyloidosis
- Dependence on pacing
Trial locations and contacts
1 site in 1 country.
United States1 site
Ochsner Medical Center
New Orleans, Louisiana, 70121
About this study
This study is being conducted to determine whether patients with advanced pulmonary hypertension when treated with cardiac resynchronization therapy improve hemodynamically and/or receive clinical benefit.
Read the detailed description
This study aims to determine whether stimulating earlier activation of the failing right ventricle in pulmonary hypertension reduces the effects of interventricular dependence in human subjects, thereby improving overall cardiac function and symptoms in patients with pulmonary hypertension and right ventricle failure with NYHA Class 3-4 symptoms.
- Conditions
- Pulmonary Hypertension
- Being tested
- Cardiac Resynchronization Therapy (CRT)
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Resynchronization Therapy (CRT)Device
A CRT device sends small electrical impulses to both lower chambers of the heart to help them beat together in a more synchronized pattern.
| Study group | Role | What they receive |
|---|---|---|
| Arms | Experimental | Pacing wires used to stimulate ventricles in a synchronous matter Receives: Device: Cardiac Resynchronization Therapy (CRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
15% increase in cardiac output at the optimal VV interval over baseline cardiac output
Primary Outcome
Measured: the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study start29 Nov 2012
- Primary completion23 Mar 2017
- Study completion23 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Daniel P Morin, MD MPH FHRS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Daniel P Morin, MD MPH FHRS, Ochsner Health System
- Investigators
- Daniel Morin, MD, Principal investigator, Cardiac Electrophysiologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03077139
- Sponsor's protocol ID
- CRT in PH
- Acronym
- CRT in PH
- Status last verified
- Sep 2017
- First submitted
- 7 Mar 2017
- Last updated
- 20 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Resynchronization Therapy in Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT03077139
- Acronym / sponsor ID
- CRT in PH / CRT in PH
- Conditions
- Pulmonary Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Dr. Daniel P Morin, MD MPH FHRSUniversity, hospital or other
- Study start
- 29 Nov 2012 (actual)
- Primary completion
- 23 Mar 2017 (actual)
- Study completion
- 23 Mar 2017 (actual)
- First posted
- 10 Mar 2017 (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.
This study is being conducted to determine whether patients with advanced pulmonary hypertension when treated with cardiac resynchronization therapy improve hemodynamically and/or receive clinical benefit.
Detailed description
This study aims to determine whether stimulating earlier activation of the failing right ventricle in pulmonary hypertension reduces the effects of interventricular dependence in human subjects, thereby improving overall cardiac function and symptoms in patients with pulmonary hypertension and right ventricle failure with NYHA Class 3-4 symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arms | Experimental | Device: Cardiac Resynchronization Therapy (CRT)Pacing wires used to stimulate ventricles in a synchronous matter |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pulmonary hypertension, defined as pulmonary artery systolic pressure greater than 40 mm Hg by transthoracic echocardiogram or right heart catheterization
- LVEF ≥ 50%
- Baseline 6MWT distant <400 meters
- Baseline NYHA Functional class ≥ III
Key exclusion criteria (13 listed)
- LVEF < 50%
- 6MWT duration > 400 meters
- NYHA Functional class < III
- Left bundle branch block
- Non-sinus rhythm
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 |
|---|---|---|
| Cardiac Resynchronization Therapy (CRT)A CRT device sends small electrical impulses to both lower chambers of the heart to help them beat together in a more synchronized pattern. | Device | Arms |
Primary outcome
15% increase in cardiac output at the optimal VV interval over baseline cardiac output
Time frame: the procedure
Primary Outcome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2017.
- 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.
Daniel Morin, MD principal investigator
Cardiac Electrophysiologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Resynchronization Therapy (CRT) in people with Pulmonary Hypertension, run by Dr. Daniel P Morin, MD MPH FHRS at 1 site in United States.
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 4 inclusion and 13 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: finished, as of the sponsor's last update on 20 Sep 2017. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
15% increase in cardiac output at the optimal VV interval over baseline cardiac output (time frame: the procedure). 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 20 Sep 2017.