Vascular DiseaseNCT00638222

Carvedilol and Micro T-Wave Alternans in Hypertensives With Chronic Kidney Disease

A study of Vascular Disease and Kidney Disease, run by University of Toledo Health Science Campus at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Evaluate effectiveness of Carvedilol CR on Micro T-Wave Alternans in high risk hypertensives Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Vascular Disease, Kidney Disease
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 6 participants
Where: 2 sitesUnited States
Study dates: May 2008to Dec 2010
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adults age 18 and older
Chronic kidney disease
Must be able to do stress test

Who cannot join

Must not be mentally disabled
Unable to provide informed consent
Unable or unwilling to comply with study protocol or procedures
Pregnancy or unknown pregnancy status in female of childbearing potential
Participation in any drug trial during the study period
Prior enrollment in this study

Show all 16Show fewer

Active liver disease
Currently on β-blocker medication at the time of enrollment
Known history of asthma exacerbation with β-blocker therapy
Second or third degree AV nodal block or bradycardia with resting heart rate <50 bpm
Prior allograft organ transplantation
Planned allograft transplantation reasonably foreseen within the active treatment period
Electrocardiographic left or right bundle branch block
Permanent implanted pacemaker
Atrial fibrillation
Ongoing treatment with any of the following medications: sotalol (Betapace), azimilide (Stedicor), quinidine (Quinidex), disopyramide (Norpace), dofetilide (Tikosyn), ibutilide (Corvert), procainamide (Procanbid), bepridil (Vascor), amiodarone (Cordarone), clarithromycin (Biaxin), erythromycin (Eryc), halofantrine (Halfan), pentamidine (Pentam), sparfloxacin (Zagam), domperidone (Motilium), droperidol (Inapsine), chlorpromazine (Thorazine), haloperidol (Haldol), mesoridazine (Serentil), thioridazine (Mellaril), pimozide (Orap), arsenic trioxide (Trisenox), cisapride (Propulsid), lidoflazine (Clinium), and methadone (Dolophine)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Site Rhode Island Hospital
Providence, Rhode Island, 02903
University of Toledo, Health Science Campus
Toledo, Ohio, 43606

Other trials in United States

About this study

Evaluate effectiveness of Carvedilol CR on Micro T-Wave Alternans in high risk hypertensives

Read the detailed description

The effect of Carvedilol CR on Micro T-Wave Alternans will be assessed in 30 hypertensives with stage 4 or 5 chronic kidney disease utilizing a cross-over design and contrasting no treatment against active treatment periods of 8 weeks.

Conditions: Vascular Disease, Kidney Disease
Being tested: Carvedilol and Placebo
Keywords: Carvedilol, Heart Disease, Vascular Disease, Kidney
Medical subject headings: Vascular Diseases, Kidney Diseases, Heart Diseases

What participants receive

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

Carvedilol and PlaceboOther
All enrolled participants were randomized to receive Carvedilol or Placebo in a 2-way crossover design. Each intervention was administered over 8 weeks before switching to the alternative intervention. The study was terminated early, and data were not unblinded so participants cannot be reported separately.

Study groups in NCT00638222
Study group	Role	What they receive
All Study Participants	Active comparator	All enrolled participants were randomized to receive Carvedilol or Placebo in a 2-way crossover design. Each intervention was administered over 8 weeks before switching to the alternative intervention. The study was terminated early, and data were not unblinded so participants cannot be reported separately. Receives: Other: Carvedilol and Placebo

What is being measured

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

Micro T- Wave Alternans
Measured: week 1, 8, 11, 18

Secondary outcomes (6)

Oxidized LDL
Measured: week 1, 8, 11, 18
Interleukin-6
Measured: week 1, 8, 11, 18
Plasma C-reactive Protein
Measured: week 1, 8, 11, 18
Plasma Cardiac Troponin T
Measured: week 1, 8, 11, 18
Plasma NT-pro BNP
Measured: week 1, 8, 11, 18
Plasma F2-isoprostanes
Measured: week 1, 8, 11, 18

Timeline

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

May 2008Dec 2010

First posted19 Mar 2008 (estimated)
Study startMay 2008
Primary completionDec 2010
Study completionDec 2010

Why it stopped: Poor enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Vascular DiseaseStudies 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: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00638222
Sponsor's protocol ID: UTHSC-08
Status last verified: Nov 2014
First submitted: 5 Mar 2008
Last updated: 13 Nov 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Carvedilol and Micro T-Wave Alternans in Hypertensives With Chronic Kidney Disease
ClinicalTrials.gov ID: NCT00638222
Acronym / sponsor ID: UTHSC-08
Conditions: Vascular Disease, Kidney Disease
Keywords: Carvedilol, Heart Disease, Vascular Disease, Kidney
Study type: Interventional
Recruitment status: TerminatedReason stopped: Poor enrollment
Enrolment: 6 participants (actual)
Lead sponsor: University of Toledo Health Science CampusUniversity, hospital or other
Collaborators: GlaxoSmithKline
Study start: May 2008
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 19 Mar 2008 (estimated)
Results: Posted 13 Nov 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Evaluate effectiveness of Carvedilol CR on Micro T-Wave Alternans in high risk hypertensives

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 1

Arm	Type	Receives
All Study Participants	Active comparator	Other: Carvedilol and PlaceboAll enrolled participants were randomized to receive Carvedilol or Placebo in a 2-way crossover design. Each intervention was administered over 8 weeks before switching to the alternative intervention. The study was terminated early, and data were not unblinded so participants cannot be reported separately.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Adults age 18 and older
Chronic kidney disease
Must be able to do stress test

Key exclusion criteria (16 listed)

Must not be mentally disabled
Unable to provide informed consent
Unable or unwilling to comply with study protocol or procedures
Pregnancy or unknown pregnancy status in female of childbearing potential
Participation in any drug trial during the study period

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
Carvedilol and PlaceboAll enrolled participants were randomized to receive Carvedilol or Placebo in a 2-way crossover design. Each intervention was administered over 8 weeks before switching to the alternative intervention. The study was terminated early, and data were not unblinded so participants cannot be reported separately.	Other	All Study Participants

Primary outcome

Micro T- Wave Alternans
Time frame: week 1, 8, 11, 18

6 secondary outcomes

Oxidized LDL
Time frame: week 1, 8, 11, 18
Interleukin-6
Time frame: week 1, 8, 11, 18
Plasma C-reactive Protein
Time frame: week 1, 8, 11, 18
Plasma Cardiac Troponin T
Time frame: week 1, 8, 11, 18
Plasma NT-pro BNP
Time frame: week 1, 8, 11, 18
Plasma F2-isoprostanes
Time frame: week 1, 8, 11, 18

Results and safety

Results posted to the registry on 13 Nov 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Carvedilol Then Placebo	0	0
Placebo Then Study Drug	0	0
All Participants	6	6

Primary outcome: Micro T- Wave Alternans

Time frame: week 1, 8, 11, 18

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Carvedilol Then Placebo	0 of 0	0 of 0	Not reported
Placebo Then Study Drug	0 of 0	0 of 0	Not reported
All Study Participants	2 of 6 (33.3%)	6 of 6 (100%)	Not reported

Limitations and caveats (from the sponsor): Early termination due to poor enrollment leading to small number of subjects to be analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)

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.

Christopher Cooper,, MD principal investigator

University of Toledo

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study of Vascular Disease and Kidney Disease, run by University of Toledo Health Science Campus at 2 sites 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 3 inclusion and 16 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: stopped early, as of the sponsor's last update on 13 Nov 2014. 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 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?

Yes. Results are posted in the registry (first posted 13 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Micro T- Wave Alternans (time frame: week 1, 8, 11, 18). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00638222.

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 13 Nov 2014.